Recall Z-3201-2026

Howmedica Osteonics Corp. · initiated July 30, 2026

Open, Classified

Product

ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0 POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)

Codes / lots: 61-3258 UDI-DI 07613327038538 Lots 191723 191867 69-2244 UDI-DI 07613327025446 Lots 990V1W D56JV4 D74X5E DX56K2 E67D6N EP10WL KP14HN NN8NM2 P36TXM P95L8X RE4EK0 X82K0D 69-2246 UDI-DI 07613327025453 Lots 8X6EL1 69-2248 UDI-DI 07613327025460 Lots 9J3DPH A41E7D AD39A3 RP673W 69-2850 UDI-DI 07613327025477 Lots MLL1M3 MLLXT1 MLLY6H 69-2852 UDI-DI 07613327025484 Lots MLL0NM MLLAHY 2099-2250 UDI-DI 07613327031430 Lots 1K5VVW 2367AK 3X0NJD 4W4MPL LV80NE 2099-2252 UDI-DI 07613327031447 Lots NV561W PM326V 2099-2256 UDI-DI 07613327031454 Lots 3H5RRK AA7JK0 2099-2861 UDI-DI 07613327031591 Lot MLLVL6 6636-0-419 No UDI Lot 13SFLA 6299-N-332 UDI-DI 07613327138870 Lot 19ECK 6302-H-632 UDI-DI 07613327138979 Lot 15NKT 690-00-22D UDI-DI 07613327025538 Lots 123J5R 194RN0 274HMK 3M77NN 5J8P89 5L82T0 986HVM A23P1X E923WW MLMEW8 MLMTVP MLNPX0 VX6813 690-00-22E UDI-DI 07613327025545 Lots 4100R9 5V78KA 711K4K EY7HL9 KP576W L620XW MD8JH9 T61W43 XA0L27 690-00-28F UDI-DI 07613327025552 Lots 284X4X 2K2DW1 E47WVY MLL8JJ MLLKAY MLLP6K MLLYT7 YE6959 690-00-28G UDI-DI 07613327025583 Lots 6D8274 9N8EWW 690-00-32I UDI-DI 07613327025590 Lots 3A2P68 4A40TV 620-00-28D UDI-DI 07613327313581 Lot MET76R 690-10-28K…

Reason for recall

Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

FDA-determined cause: Process change control

Action taken

Firm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.

Details

Recall number
Z-3201-2026
Initiated
July 30, 2026
Posted by FDA
September 16, 2026
Product code
KWZ – Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Quantity
12,156 US
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Recalling firm
Howmedica Osteonics Corp., Mahwah, NJ

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3195-2026 AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3196-2026 OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3197-2026 ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3198-2026 TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3199-2026 ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3200-2026 DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3202-2026 BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3203-2026 SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3204-2026 TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3205-2026 SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified
Z-3206-2026 SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… 07/30/2026Open, Classified